Ostomy/Fistula Bag

ABSTRACT

A lesion or fistula isolating bag, the bag defining a first chamber having a closeable entrance and a second chamber for application to a lesion or fistula and wherein access to the second chamber is made through the first chamber via a valve, the valve being arranged to inhibit passage of fluid from the second chamber to the first, and to allow said access from the first chamber to the second, the bag further comprising a closure for said closeable entrance.

The present invention relates to devices for providing access to alesion—such as an ostomy or wound—or to a fistula on a person or animal(hereinafter generically referred to as a “wound”) whilst isolating thewound from a surrounding environment. More specifically, the inventionrelates to an ostomy, fistula or wound drainage bag for this purpose.

Various devices are known for the dressing of wounds on persons oranimals which simultaneously allow access to the wound for inspectionand/or for treatment whilst isolating the wound from the surroundingatmosphere. For example, a device known in the art is shown in FIG. 1.The device 10, sometimes known as a window bag, is applied to the skinof the patient 12 over the wound 18. The device consists of a body 14which is often of generally circular cross-section and has a lid 16which may be removably fixed to the body 14 to isolate the wound fromthe surrounding environment. Access to the wound may be made by removingthe lid 16. These lids and bodies are of generally circularcross-section as the shape tends to allow a more efficient seal whencompared to lids and bodies of other shapes.

Another type of device that is known in the art is disclosed in UnitedStates Design Pat. No. 432,232. This document discloses a wound drainagedevice which allows access and isolation for the wound and includes azip fastener access for this purpose.

Such devices have several inherent disadvantages. These include the factthat the seals are not particularly efficient; i.e. the zip of US DesignPat. No. 432,232 may not be particularly water tight. Further, neitherdevice offers efficient isolation of the wound from the surroundingatmosphere if the lid is not properly sealed.

It is an object of the present invention at least to alleviate theseproblems.

The invention is set out in the claims.

Embodiments of the present invention provide advantages over the priorart by providing a bag device with first and second chambers and a seal,or valve, between the chambers which inhibits the passage of fluidbetween the chambers but also allows access for inspection and/ortreatment of the wound. In one embodiment of the present invention, thisis achieved by providing two or more members which extend inside the bagfrom its opening and which close to form the valve. In anotherembodiment of the present invention, the valve is effected by providinga flexible partition which divides the chambers. Access is made to thesecond chamber from the first chamber through the flexible partitionwhich has two layers, each layer having a respective slit which isoffset from the other. Such an arrangement offers effectively a“zig-zag” set up which is the extra “seal” or “valve” in the device andtherefore extra protection for the patient's wound. It would of coursebe possible to extend this arrangement so that the flexible partitionhas more than two layers, each layer having its own slit.

A further advantage of the present invention is that embodiments may beautomatically manufactured using machinery. Many of the devices in theprior art must be manufactured by hand.

Applications of the device of the present invention include applicationto a wound as defined above. In such an application utilisingembodiments of the present invention, the bag is fixed to a patient overa wound that he or she has. The user (a doctor or nurse) may open thebag at the entrance and enter his/her hand into the bag and the firstchamber. Access can be gained to the wound for inspection and/or furthertreatment of the wound through the valve and the second chamber.

Embodiments of the present invention will now be described, by way ofexample only, and with reference to the accompanying drawings in which:

FIG. 1 is a diagram showing a window bag as known in the prior art;

FIG. 2 is a diagram showing an embodiment of the present invention;

FIG. 3 is a diagram showing another embodiment of the present invention;

FIG. 4 is a diagram illustrating the manner in which the seal may beoperated in the embodiment of FIG. 3;

FIG. 5 is a diagram illustrating a further embodiment of the presentinvention;

FIG. 6 is a diagram illustrating the manner in which the seal operatesin the embodiment of FIG. 5 of the present invention;

FIG. 7 shows a yet further embodiment of the present invention; and

FIG. 8 shows yet another embodiment of the present invention.

Referring now to FIG. 2 an embodiment of the present invention isillustrated. The bag 4 comprises an opening or entrance 6, chambers 7 aand 7 b and a valve 9 which isolates one chamber from the other. The bagis placed over the wound 8 of the patient 2 and the user enters his orher hand through the bag entrance 6 into the first chamber 7 a. Thevalve 9 opens, or access is gained through it, for the user to inspector treat the wound. Operation of the valve 9, which may take severalforms, is discussed below.

Referring now to FIG. 3, a device 110 according to an embodiment of thepresent invention is illustrated. The device 110 comprises first andsecond chambers 114, 116 and a closeable aperture 118 which may beprovided by a lid, zip fastener or other suitable closure means. The twochambers 114, 116 are separated by a partition comprising two adjacentlayers 120, 122 each of which has a respective slit 124, 126. As isillustrated, the slits may be oriented in the same direction, but offsetfrom one another. The slits need not be parallel to one another, but maysimply be oriented in substantially the same direction. It will also beappreciated that the openings in the layers need not be by means ofslits, but may be by any suitable shape of opening.

In use, the device 110 is affixed to a patient's skin 112 and over awound thereon (not shown). An outer surface of the device is adherent(for example, the outer surface may be coated in adhesive) in order toaffix or attach it to a patient. Coating the outer surface of thechamber with adhesive offers a convenient and easy method of fixing thedevice to the patient. Preferably, the adhesive is of a type approvedfor medical use such that it does not irritate the patient's skin orprovide any risk of infection to the wound.

In an embodiment of the invention, the first layer 120 of the partitionmay be heavier than the second layer 122. In this way, the forming ofthe seal/valve when the user's hand is withdrawn from the device isenhanced; the additional weight of the first layer of the partitionpresses down on the second layer such that it presses close against thepatient's body thereby forming the seal. Various means may be used toachieve this additional weight in the first layer, for example, it maybe formed of a material which is more dense than the material of thesecond layer, and/or the material of the first layer is of greaterthickness than the material of the second layer.

In embodiments of the present invention the closeable aperture 118 inthe first chamber is sealable, so that the aperture 118 is watertight.In other embodiments of the invention, the aperture is sealable so thatit is airtight thereby increasing the sterility of the device.

In embodiments of the present invention the device is made from flexiblepolymer, for example, any of polyethylene (PE), polyvinyl chloride (PVC)and ethyl (or ethylene) vinyl acetate (EVA). Such polymers offerflexible and convenient-to-manufacture materials for the construction ofthe chambers or bag. Typically, the first layer 120 of the partition (orfirst chamber itself) is constructed from PE and the second layer 122 ofthe partition (or second chamber itself) is constructed from EVA. Otherolefins or polyolefins might also be used. In this instance, PE is aslightly heavier material than EVA and, as such, assists the forming ofthe seal as described above.

In an embodiment of the present invention, the offset between the slitsis between 15 to 30 mm. However, the offset between the slits may bebetween 5 mm and 100 mm or between 10 mm and 50 mm.

In an embodiment of the invention, the slits 124 and 126 are between 80mm and 300 mm long depending on the overall size of the device. It hasbeen found that slit lengths in this range offer convenient accesswithout compromising the integrity of the seal offered by the partition.

Referring now to FIG. 4 the manner in which the seal operates and inwhich a user may gain access to a wound through the device is nowdiscussed. FIG. 4 a shows a cutaway of the device 110 illustrating thelayers 120 and 122 in relation to the patient's skin 112. The wound onthe patient's skin is not shown for the sake of clarity. Also shown inthe first layer 120 is the slit 124 and in the second layer 122 is shownthe slit 126. As mentioned above, these slits are offset from oneanother. The user gains access to the first chamber 114 by opening thecloseable aperture 118 which is shown in FIG. 3. The user then opens theslit 124 which opens as shown in FIG. 4 b as the layer is made of aflexible polymer and then accesses the opening by pushing through in thedirection 128 as shown and then through the slit 126. As the secondlayer 122 is also made from flexible polymer, as discussed above, theuser has access directly through both layers to the wound for inspectionand/or treatment.

Referring now to FIG. 5, another embodiment of the present invention isnow discussed. In this embodiment 210 of the device the first and secondchambers are formed by the joining together of two bags or bag portions214, 216. The two bags 214, 216 are welded together at 230 as shown inFIG. 5 b. Various methods of welding may be employed for this purpose,the most suitable having been found to be thermal welding,radio-frequency welding or impulse welding.

In this embodiment, the width of the bag (dimension 234 as shown in FIG.5 a) is approximately 50 mm. A bag of this size offers sufficient widthfor the user to manipulate the chamber or bag to open it, and access theslits 224, 226 in order to access to the patient's wound. Of course, itwill be appreciated that other dimensions of this magnitude, say between200 and 20 mm, or between 150 and 25 mm, or 100 and 30 mm, or 75 and 40mm may be used depending on the requirements of the particularapplication.

The closeable aperture 218 is formed by means of a plastic (or othersuitable material) zip fastener which offers convenient closeable accessto the first bag. Plastic zip fasteners on their own are inefficient atproviding fluid containment, but coupled with the seal/valve offered bythe flexible partition with offset slits, the device offers a secureseal to contain any fluid which may be discharged by the patient'swound.

Alternatively, and as mentioned in the preceding example, the closeableaperture is effected by a removable cover such as a lid. Any other typeof closing may be used such as button fasteners, but it is preferablethat the aperture is sealable.

As mentioned above, the two bags are welded together around the slits at230. The zipper weld may be inset to allow the zipper the freedom to beopened easily by the user as shown at 236.

The width of the first bag (zipper bag) is determined such that it suitsthe dimensions of the second bag (wound bag).

The slit 224 in the first bag 214 should be at the bottom of the firstbag while the slit 226 in the second bag 216 is situated close to theweld adjacent to the zip 214.

In embodiments of the present invention a further aperture 232 may beprovided in device 210. Multiple further apertures may be provided but asingle aperture 232 is illustrated for the sake of simplicity. Thisaperture (or apertures) may be multi-purpose in that it could be usedfor the draining of any fluid which is discharged by the wound, forwound irrigation or, could possibly be used for sterile access to thewound, for, for example, an intravenous drip to the patient.

The manner in which access may be effected to the patient's wound withan alternative embodiment is now illustrated in FIG. 6. The slits 224,226 are shown in the first and second bags 214, 216. When a user insertshis or her hand through the aperture 218 (the zipper aperture 218 asshown open in FIG. 6), the action of raising the aperture 218 causes thelayer 220 of the bag to move in the manner illustrated in FIG. 6 b.Access may then be made to the second bag 216 in the direction 228 asshown.

FIG. 7 illustrates a further alternative embodiment of the presentinvention which shows an alternative version of the valve of FIGS. 3 to6. In this embodiment the zip 318 is situated on an outside edge of thebag 314, in this case at the open top of the wound bag which is attachedto the patient 316 over the wound 324. Each side of the zip strip iswelded to the front and back of the bag respectively as shown at 330.The valve 334 is effected by members which extend away from the zipfastener into the bag 314 and is effective when the zip is closed.Access is obtained to the zip bag interior 314 through the open zip 318,the valve 334 so that the wound 324 may then be accessed. Such a valvewhich is integral with the zip 318 offers a further level of security tothe device so that the likelihood of any leakage of wound discharge orof infection to the wound is greatly reduced.

As a further alternative, this valve embodiment could be used inconjunction with the valve of FIGS. 3 to 6 to provide enhanced isolationbetween the opening and the wound.

The aperture 320 provides a means for passage of fluid into and/or outof the bag.

Referring now to FIG. 8, a further example of an embodiment of thepresent invention is shown. This embodiment is a variant of theembodiment of FIG. 3, and like reference numerals refer to like parts.The device 110 of FIG. 8 comprises, again, first and second chambers 114and 116 and a closeable aperture 118 which, in this example, is in theform of zip fastener. The two chambers 114, 116 again are separated by apartition comprising two adjacent layers 120, 122 each of which has arespective slit 124, 126. The slits may be orientated in the samedirection, but offset from one another although, as mentioned above,this is not absolutely necessary; the slits may simply be oriented insubstantially the same direction. Again, the openings in the layers neednot be by means of slits, but may be by any suitable shape of openings.Operation of the device is as described above with reference to FIG. 3.

It will be understood that the present invention has been describedabove purely by way of example and modifications of detail can be madewithin the scope of the invention.

Each feature disclosed in the description and the claims and drawingsmay be provided independently or in any appropriate combination.

It will also be appreciated that features of one aspect of the inventionmay be applied to features of another aspect of the invention.

1. A lesion or fistula isolating bag comprising: a first chamber havinga closeable entrance; a second chamber for application to a lesion orfistula, wherein access to the second chamber is made through the firstchamber via a valve arranged to inhibit passage of fluid from the secondchamber to the first and to allow said access from the first chamber tothe second; and, a closure for said closeable entrance.
 2. A bagaccording to claim 1, wherein the closeable entrance is sealable.
 3. Abag according to claim 1, wherein said valve includes at least twomembers which extend inside the bag and, when the closure is in a closedstate, said members close to form the valve.
 4. A bag according to claim1, wherein the valve comprises a flexible partition dividing the firstand second chambers and comprising first and second adjacent layers witheach layer including an aperture, the respective apertures being offsetone from the other.
 5. A lesion or fistula isolating bag comprising:first and second chambers, one of which has a closeable opening foraccess, wherein the chambers are divided by a flexible partitioncomprising first and second adjacent layers with each layer including anaperture, the respective apertures being offset one from the other.
 6. Abag according to claim 4 in which each aperture comprises a respectiveslit.
 7. A bag according to claim 6 in which the slits extend generallyparallel to one another.
 8. A bag according to claim 4, wherein thefirst layer is formed of a material which is heavier than the materialof the second layer.
 9. A bag according to claim 4, wherein one layer isthicker than the other.
 10. A bag according to claim 6, wherein theoffset between the slits is between 5 mm and 100 mm.
 11. A bag accordingto claim 6, wherein the slits are between 80 and 300 mm long.
 12. A bagaccording to claim 4, wherein the bag comprises first and second bagportions, the first chamber being formed by the first bag portion andthe second chamber being formed by the second bag portion.
 13. A bagaccording to claim 4, wherein said closeable entrance is located on anouter edge of the first chamber.
 14. A bag according to claim 4, whereinthe closure is a zip fastener.
 15. A bag according to claim 4, whereinthe closure is a removable cover such as a lid.
 16. A bag according toclaim 4, wherein the bag includes a further aperture for the passage offluid between atmosphere and the device.
 17. A bag according to claim16, wherein the further aperture comprises a drain.
 18. A bag accordingto claim 4, wherein an outer surface of the second chamber is adherent.19. A bag according to claim 4, wherein the first chamber has at leastone overall dimension approximately equal to 50 mm.
 20. A bag forisolating a lesion or fistula comprising: a vessel comprising a firstwall of flexible material with a first slit and a second wall oppositethe first wall with a closeable opening; a bag including a second slit;wherein the vessel and bag are joined with one another such that thefirst and second slits are oriented in the same direction and areadjacent to, but offset from, one another and the joint surrounds anarea encompassing the first and second slits.
 21. A bag according toclaim 1, wherein the bag is made from flexible polymers selected from agroup consisting of polyethylene, polyvinyl chloride and ethyl vinylacetate.
 22. A bag according to claim 12, wherein there is a jointbetween the first and second bags and the joint is made by a weldingprocess selected from the group consisting of thermal, radio-frequencyand impulse welding.
 23. (canceled)